GI Dynamics (ASX:GID) today touted new safety and efficacy data on its EndoBarrier device designed for weight loss, claiming meaningful improvements in hemoglobin A1c levels and weight reduction in study participants.
The trial avoided previous issues involving liver abscesses that forced the halt of a U.S. clinical trial for the EndoBarrier device in July last year.
Data was presented at the Endocrine Society’s ENDO 2016 meeting in Boston this week.
“As a clinician, it is particularly gratifying to meet patients treated with EndoBarrier Therapy and hear them report their many individual improvements in overall health. Patients report considerable improvements in exercise tolerance, reductions in breathlessness, and a general sense of well-being. We also see substantial reduction in the need for other diabetes medications, particularly insulin, which is often no longer required. Usually, patients are especially pleased about this,” study chief investigator Dr. Bob Ryder of the West Birmingham Hospitals NHS Trust said in prepared remarks.
Data from the study indicated that patients receiving EndoBarrier treatment along with liraglutide showed the largest benefit in both reduced hbA1c levels and weight loss, the Lexington, Mass.-based company said.
When combined with EndoBarrier treatment, patients on liraglutide required less medications than those who did not receive the EndoBarrier treatment, with average doses at 1.2 mg and 1.8 mg respectively. In addition, 6 subjects in the combined-therapy arm reported a reduction in diabetes medications.
“This encouraging data is further clinical validation of EndoBarrier Therapy. We are delighted to see that EndoBarrier Therapy, administered alone or in combination with diabetes medication, compares favorably to treatment with pharmacotherapy. The mean baseline starting HbA1c level for EBT-plus-liraglutide group was 9.6 %. The treatment target is the reduction of HbA1c to less than 7.5 %, which is a mean reduction greater than 2.1%. We were excited to see EBT-plus-liraglutide patients attain a 2.1 % absolute reduction, which is a 95.4% overall attainment of target. In addition, 54.2% of patients attained the < 7.5% HbA1c treatment target.” CEO Scott Schorer said in a prepared statement. “We will continue to support investigator-initiated studies around the world and sincerely appreciate the efforts of Dr. Bob Ryder, Dr. Piya Sen Gupta and their colleagues as they continue to expand the body of evidence supporting the use of EndoBarrier Therapy.”
Weight loss between groups was 11.3% for those treated with both the EndoBarrier and liraglutide, 10.8% for those treated with the EndoBarrier only and 3.5% when treated with only liraglutide. HbA1c reductions were 2.1%, 1.2% and 1.3% respectively.
All serious device-related adverse events in EndoBarrier-treated patients were resolved after device removal, and 1 liver abscess was discovered that did not require device removal and was resolved with antibiotics.
“This is the first study in which the combination of a GLP-1 receptor agonist and the EndoBarrier intestinal device has been used to successfully treat diabetes and obesity. The combination seems to result in the best improvements in glucose control and weight reduction. EndoBarrier is less invasive than surgery, achieves a similar level of bypass and can be inserted as a simple and quick outpatient endoscopic procedure that patients are likely to find more acceptable. They have one year in which to change their eating behavior; EndoBarrier helps them do this,” study research fellow Dr. Piya Sen Gupta of King’s College Hospital London said in a press release.
GI Dynamics said last March that the FDA halted enrollment in the 325-patient Endo trial after some patients developed bacterial infections known as hepatic abscesses. The company said it would explant all patients in the trial over the next few months as it halts the trial, after it couldn’t come to an agreement with the FDA about continuing the study.
GI Dynamics, which sacked chief medical officer Dr. David Maggs for cause last year, said there were 7 cases of hepatic abscess in the trial, for an incidence rate of roughly 3.5%. That’s nearly double the 2% safety threshold, the company said, noting that the rate outside the U.S. is about 0.73% “based on experience with approximately 3,000 units shipped commercially since 2009.”